PsiOxus
Therapeutics, Ltd. (PsiOxus) has treated the first patient in
its phase I/II clinical trial of ColoAd1
for the treatment of metastatic solid tumours. The Evolve (EValuating
OncoLytic Vaccine Efficacy) study is the
first clinical trial of the systemically available oncolytic
vaccine ColoAd1, a highly potent, broad-spectrum, anti-cancer
therapeutic capable of destroying tumour cells at minute concentrations.

PsiOxus will conduct the multinational Phase I/II study at up to 20
sites in Europe. Regulatory approvals to proceed with the study have so
far been received for the UK, Spain and Belgium. The safety, biological
activity and efficacy of ColoAd1 will be evaluated in 126 patients, with
initial results expected by the end of 2013. The first patient was dosed
this week at a site in Belgium.

ColoAd1 was developed using the evolutionary principle of natural
selection to generate an oncolytic vaccine with optimal anti-cancer
properties. The vaccine is injected into the bloodstream, and is then
delivered to the cancer sites, where it replicates inside of cancer
cells and kills them. Each infected cell produces thousands of new
copies of ColoAd1, which spread to nearby cancer cells and kills them,
as well, while ignoring normal cells. The approach represents a new
generation of so-called "self-amplifying" cancer therapy that has the
effect of killing tumours and acting as a cancer vaccine.

Dr
John Beadle, CEO of PsiOxus, commented: "The Evolve study is a major
milestone for both PsiOxus and ColoAd1 as we test a new form of
anti-cancer agent with greatly improved selectivity for tumour cells in
humans for the first time. While there remains much work to be done, the
Evolve study could forge a path to a new treatment option for patients
with metastatic cancer. The advantage of this type of cancer vaccine is
that the immune response will be specific for each patient's own
personal cancer."

The Principal Investigator and Independent Oncologist of the Evolve
Study is Professor Josep Tabernero from the Vall d'Hebron University
Hospital in Barcelona. The trial is funded from the recent £22 million
(US$34 million) investment made by Imperial Innovations, SROne,
Lundbeckfond Ventures and Invesco Perpetual, as well as £1.8 million of
support from the Wellcome Trust. The phase I component is currently
recruiting patients with solid tumours and who have no further
conventional treatment options open to them. This initial phase aims to
establish a safe dose schedule for ColoAd1 in cancer patients. The phase
II component will then recruit patients with metastatic colorectal
cancer and who have already received standard first-line therapy. The
primary endpoint of the phase II component is Progression Free Survival
(PFS) when compared to patients receiving standard therapy alone.
Secondary endpoints include response rates and overall survival.

ColoAd1 is highly effective at selectively targeting and killing cancer
cells while having little or no activity on normal tissue. ColoAd1 has
been shown to be up to 1,200 times more potent at killing human cancer
cells than non-cancerous human cells. Standard chemotherapy agents are
much less selective for cancer cells, accounting for the often-severe
side effects of chemotherapy. Importantly, scientists in Professor Len
Seymour's laboratory at the University of Oxford, UK have shown that
ColoAd1 survives very well in human blood.

According to Prof Seymour: "This characteristic is fairly unique to
ColoAd1 and is not shared with many other viruses. This means that
ColoAd1 can be delivered efficiently by intravenous infusion, which is a
significant advantage over many other oncolytic viruses in development.
The blood stream will carry the ColoAd1 to all metastatic cancer sites
in the body, where they can self-amplify at the site of action, making
this a very exciting step forward in the field."

The initial target indications for ColoAd1 are metastatic colorectal
cancer and primary hepatic cellular carcinoma. These are both
exceptionally large market segments with significant unmet medical need.
The incidence of colorectal cancer is forecast to reach nearly 500,000
cases by 2018. Primary hepatic cellular carcinoma is the third leading
cause of cancer mortality worldwide, and remains a significant unmet
medical need with few effective treatment options.

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